FDA inspection

Hainan Simcere Pharmaceutical Co., Ltd.: FDA inspection ending Nov 8, 2019

FDA inspection 1111288 · Voluntary Action Indicated (VAI) · Haikou

Key facts

Inspection ID 1111288
Firm Hainan Simcere Pharmaceutical Co., Ltd.
FEI number 3015251693
Address Pharma Valley, No. 2 Yaogu 3rd Road; Xiuying District
City Haikou
Fiscal year 2020
Inspection end date Nov 8, 2019
Classification Voluntary Action Indicated (VAI)
Project area Generic Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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